RADIATION CONTROL - REGISTRATION OF RADIATION MACHINES, FACILITIES AND SERVICES PART 2: REGISTRATION OF RADIATION MACHINES, FACILITIES AND SERVICES

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1 DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT Hazardous Materials and Waste Management Division RADIATION CONTROL - REGISTRATION OF RADIATION MACHINES, FACILITIES AND SERVICES 6 CCR Part 02 [Editor s Notes follow the text of the rules at the end of this CCR Document.] PART 2: REGISTRATION OF RADIATION MACHINES, FACILITIES AND SERVICES 2.1 Purpose and Scope Authority Rules and regulations set forth herein are adopted pursuant to the provisions of sections , (1)(l), and , CRS Basis and Purpose Scope A statement of basis and purpose of these regulations accompanies this part and changes to this part. A copy may be obtained from the Department This part provides for: Applicability. (1) Registration of facilities; (2) Certification of radiation machines; (3) Registration of persons providing radiation machine services including assembly, installation, maintenance and repair; (4) Registration of qualified inspectors and qualified experts; and (5) Approval of mammographers and other operators The requirements and provisions of this part apply to each registrant or applicant for registration subject to this part unless specifically exempted The provisions of this part are in addition to (and not in substitution for) other applicable provisions in Parts 1, 4, 5, 6, 7, 8, 9, 10, 24 and other parts of these regulations Published Material Incorporated by Reference Published material incorporated in Part 2 by reference is available in accord with Definitions. Code of Colorado Regulations 1

2 2.2.1 Definitions of general applicability to these regulations are in Part 1, section As used in Part 2, each term below has the definition set forth. ARRT means the American Registry of Radiologic Technologists. ARRT(R). See radiologic technologist. ASRT means the American Society of Radiologic Technologists. Assembler means any person engaged in the business of assembling, replacing, or installing one or more components into a radiation machine system or subsystem. Calibration means to adjust and/or determine the: (1) Response or reading of an instrument relative to a series of conventionally true values; or (2) Strength of a radiation source relative to a standard or conventionally true value. Certification Evaluation (CE) means the evaluation of a radiation machine at a facility by a qualified inspector or the Department for the purpose of ascertaining the performance of the radiation machine system and/or facility in order to determine conformance with these regulations. Direct supervision means the supervisor is present in the facility and immediately available to furnish assistance and direction to the supervisee throughout the performance of a procedure. (1) The direct supervisor is not required to be present in the room when the procedure is performed. (2) Direct supervision during the performance of a mammography examination means that the supervisor is present to observe and correct, as needed, the performance of the individual being supervised who is performing the examination. Examination means performing a procedure, including selection of exposure settings, positioning the x-ray system and the patient, and initiating and terminating the exposure. Facility means, for purposes of Part 2, the location within one building (or vehicle, or under one roof, or at one address) and under the same administrative control, at which a radiation machine is or was installed, operated and/or located. FDA means the United States Food and Drug Administration. Intercomparison means the direct comparison, in accord with , of two instruments designed to measure the same physical quantity. Limited-scope operator means an individual who has taken and passed a required test and has approval by the Department pursuant to to operate x-ray systems and to conduct specified radiographic examinations of the chest, extremities, skull, hip/pelvis and spine/sacrum. LSO means limited-scope x-ray machine operator, abbreviated by the ASRT as LXMO, limited x-ray machine operator. Code of Colorado Regulations 2

3 MQSA means Mammography Quality Standards Act. NIST means the National Institute of Standards and Technology. Operator means an individual adequately trained in accordance with these regulations in the purpose and experienced in the practice of performing a radiographic examination. Performance adjustment means the adjustment or repair of a function (not including the setting of operator-selectable functions, such as time, ma and/or kvp for an individual exposure) of an x ray machine or imaging system that is required to bring the machine into compliance with these regulations and the specifications. Provisional qualified inspector (PQI) means an individual who meets the applicable requirements of Appendix 2I and has current Department approval in a designated specialty to perform, under the general supervision of a qualified inspector, evaluations of radiation machines, facilities, and operators for compliance with these regulations. QE(R) means a qualified expert medical physicist designated for radiographic imaging. QE(S) means a qualified expert physicist designated in other than the healing arts. QE(T) means a qualified expert medical physicist designated for radiation therapy. "Qualified expert" (QE) means an individual who as provided in meets the applicable requirements of Appendix 2B or 2C and has current Department approval in a designated specialty to evaluate radiation shielding design and recommend radiation safety practices. Qualified inspector (QI) means an individual who as provided in meets the applicable requirements of Appendix 2I and has current Department approval in a designated specialty to perform evaluations of radiation machines, facilities, service providers and operators for compliance with these regulations. Qualified mammographer means a mammographer who as provided in meets the applicable requirements of Appendix 2M and has current Department approval. Qualified trainer (QT) means an individual whose training and experience adequately prepares the individual to carry out specified training assignments as illustrated in Appendix 2J. Radiologic technologist means an individual who is currently registered in radiologic technology with the American Registry of Radiologic Technologists, designated ARRT(R). Registered medical physicist (RMP) means an individual who meets the applicable requirements of Appendix 2B and has current Department approval to perform medical physics activities in a designated specialty, including to design shielding, measure ionizing radiation, and oversee radiation protection, quality assurance and clinical medical physics for radiation therapy, computed tomography, mammography and/or other healing arts facilities. Service company means a person who is engaged (or offers to engage) in the business of selling, leasing, transferring, lending, assembling, installing, maintaining, repairing, storing, trading out, or disposing of radiation machines and their related components, or is engaged in the business of furnishing or offering to furnish radiation machine servicing or services. Service technician means an individual who is employed by a service company to perform radiation machine servicing or services. Code of Colorado Regulations 3

4 Shielding design means physical specifications, such as room layout, floor plan, construction materials, and equipment configuration, to demonstrate compliance with the radiation limits set forth in Part 4 of these regulations. EXEMPTIONS FROM THE REGULATORY REQUIREMENTS 2.3 Exemptions Electronic equipment that is not designed primarily to produce radiation is exempt from the registration and notification requirements of Part 2, provided that the dose equivalent rate averaged over an area of 10 cm2 does not exceed 5 µsv (0.5 mrem) per hour at 5 cm from any accessible surface of such equipment Radiation machines while in transit or storage incident thereto are exempt from the requirements of Part Domestic television receivers, computer monitors, and similar devices are exempt from the requirements of Part A radiation machine that is out of service yet kept at a facility is exempt from the registration and certification evaluation requirements of Part 2 if the Department has received documentation, on Form R 61, Disposition of a Radiation Machine, signed by a service technician, or equivalent signed form, that the radiation machine has been made physically inoperable by inactivating or dismantling the electrical circuitry such that the radiation machine is not capable of producing radiation An electron microscope or electron microprobe is exempt from Part 2 provided that: A survey shows compliance with 2.3.1; or The device is not capable of exceeding an operating voltage of 50,000 electron volts The legal owner of electronic equipment which meets the requirements of but which is not specifically exempted under 2.3.2, 2.3.3, and shall maintain for the lifetime of the equipment radiation measurement results or certification from the manufacturer or a qualified expert indicating that the equipment complies with the exposure rates specified in REQUIREMENTS FOR DEPARTMENT APPROVAL AND/OR REGISTRATION 2.4 State of Colorado Authorization or Approval Recognized by the Department is Required for Each Category Designated in This Section Registration of a Facility Each person possessing or in the process of coming into the possession of a radiation machine facility shall: (1) Be registered with the Department; (2) Apply for registration of such facility with the Department prior to using a radiation producing machine at the facility; (3) Complete and submit an application for registration on Department Form R-4, and include all of the information required by the form and any accompanying instructions, together with the required fee(s); Code of Colorado Regulations 4

5 (a) Designate a radiation safety officer who meets the applicable requirements of Appendix 2A to be responsible for overall radiation protection for the facility; (b) Attest that a policy is in place for keeping up to date a written or electronic list of all operators who have demonstrated adequate radiation safety training and experience, as prescribed by and the applicable appendices of parts of these regulations; and (c) Attest that a written shielding design, if required, has been: (i) Completed, or will have been completed, in accordance with and Appendices 6A, 6B and 6C of these regulations, prior to any radiation machine installation; and (ii) Placed and retained on file at the facility for the life of the facility As prescribed by for a healing arts screening program, complete and submit Form R-300, Application for Registration - Healing Arts Screening, including all of the information required by Appendix 6F and/or Form R-300 and any accompanying instructions, together with the required fee(s) In addition to the other requirements of 2.4, any research using radiation machines on humans shall be approved by an Institutional Review Board (IRB) If radioactive materials are also present at the facility, the requirements of Part 2 apply as appropriate to coordination with the equivalent licensee or application for a license Registration as a Service Company Each person who is engaged (or offers to engage) in the business of selling, leasing, transferring, lending, assembling, installing, maintaining, repairing, storing, trading out, or disposing of radiation machines and their related components, or is engaged in the business of furnishing or offering to furnish radiation machine servicing or services in this State, shall be registered with the Department prior to furnishing or offering to furnish any such service Application for registration shall be completed on Form R-60, Application for Registration - Radiation Machine Servicing and Services, and shall contain all of the information required by the Department as indicated on the form and all accompanying instructions, together with the required fee(s) Each person applying for registration under shall identify and provide: (1) The specific services for which registration is being requested, including but not limited to: (a) Engaging (or offering to engage) in selling, leasing, transferring, lending, assembling, installing, maintaining, repairing, trading out, or disposing of radiation machines and associated radiation machine components; and (b) Servicing of radiation machines and associated radiation machine components; and Code of Colorado Regulations 5

6 (c) Performance adjustment to or calibration of radiation machines, measurement instruments, and devices; and (2) The name and qualifications of each service technician who will provide service, including: (a) Documentation of the training and experience that demonstrate, as required by Appendix 2H, sufficient competence to provide the services for which registration is being requested; and (b) Certification that each service technician has been instructed in the requirements of these regulations and of the Federal Performance Standard (21 CFR Chapter I, Subchapter J, April 1, 2010), and demonstrated an understanding thereof; and (3) The type of personnel dosimetric monitoring supplied, frequency of reading, and replacement or exchange schedule as appropriate (see 4.17 and 4.18); and (4) The type of measurement instruments that will be used to determine compliance with these regulations, including: Registration as a Qualified Expert. (a) The frequency of calibration; and (b) The provider of calibration services; and (c) A written commitment to meet the instrument calibration requirements specified in Each individual who offers the service of designing and/or evaluating shielding to meet the requirements of shall be registered with the Department as a qualified expert designated QE(R), QE(S) and/or QE(T). (1) For a healing arts facility, each shielding design shall be completed as specified in Part 6 by a registered medical physicist who: (a) Meets the criteria established in Appendix 2B; and (b) Has a current Department Notice of Registration as a QE(R) for radiography and/or QE(T) for radiation therapy. (2) For other than a healing arts facility, each shielding design shall be completed by a qualified expert who: (a) Meets the criteria established in either Appendix 2B for a registered medical physicist or Appendix 2C for any other physicist, designated QE(S); and (b) Has a current Department Notice of Registration as QE(R), QE(S) and/or QE(T) Each individual who offers the service of calibration and compliance surveys for a radiation therapy unit shall be registered with the Department as a registered medical physicist who meets the criteria in Appendix 2B and has current Department approval as a registered qualified expert for radiation therapy, designated QE(T). Code of Colorado Regulations 6

7 The application for registration shall be submitted on Form R-68, Application for Registration - Qualified Expert, and include all of the information required by the form and any accompanying instructions, together with the required fee(s) Registration as a Qualified Inspector Each individual who offers the service of performing a certification evaluation of a radiation machine and/or facility evaluation shall be registered with the Department as a qualified inspector who meets the criteria established in Appendix 2I The application for registration shall be submitted on Form R-53, Application for Registration - Qualified Inspector, and include all of the information required by the form and any accompanying instructions, together with the required fee(s) Department approval as a registered medical physicist consistent with Appendix 2B is considered also to be Department approval as a qualified inspector for any facility and/or machine Measurements shall be made with instruments that are sufficiently sensitive to determine compliance with these regulations Approval of an Operator. (1) The instruments shall be maintained and used in good working order. (2) Notwithstanding the requirement of , such equipment shall be calibrated every two (2) years, or in accordance with the manufacturer's recommendation, whichever is more frequent, or after any repair that could affect the calibration. (3) Calibrations shall be NIST-traceable where such traceability is feasible. (4) In lieu of calibration, instrument accuracy may, with Department approval, be determined by (inter)comparison with a suitable and appropriately calibrated instrument. (5) Each (inter)comparison protocol shall be submitted to the Department for review and approval. (a) The comparison shall be between an instrument that has a current calibration traceable to NIST and an instrument for which a calibration factor is to be determined. (b) The comparison shall be made using the actual physical quantity to be routinely measured (for example, radiation energy/quality or visible light spectrum) and shall be compared in the same physical geometry. (6) Instruments used for the certification evaluation report to measure the air kerma or air kerma rate of mammography machines shall be calibrated at least once every two (2) years and each time the instrument is repaired. (a) The instrument calibration shall be NIST traceable; and (b) The instrument shall be calibrated with an accuracy of ± six (6) percent (95 percent confidence level) in the mammography energy range. Code of Colorado Regulations 7

8 X-ray Machine Operator Subject to Appendix 2D. (1) Consistent with and governed by 2.6.1, prior to operating an x-ray system on living humans in the State of Colorado, each individual shall meet the x ray machine operator adequate radiation safety training and experience criteria established in Appendix 2D, in particular 2D.2.4 for a limited scope x-ray machine operator. (2) Application for renewal as a limited scope x-ray machine operator, accompanied by the required fee(s) and evidence of 24 hours of continuing education as prescribed in Appendix 2D and not inconsistent with 2.6.1, shall be submitted at least thirty (30) calendar days prior to the expiration of each two year registration period Computed Tomography Operator Subject to Appendix 2E. (1) Consistent with and governed by 2.6.1, prior to operating a computed tomography system on living humans, each individual shall at minimum meet the Computed Tomography Operator adequate radiation safety training and experience criteria established in Appendix 2E Bone Densitometry Equipment Operator (BDEO) Subject to Appendix 2F. (1) Consistent with and governed by 2.6.1, prior to operating a bone densitometry x ray system on living humans, each individual shall at minimum meet the Bone Densitometry Equipment Operator adequate radiation safety training and experience criteria established in Appendix 2F, in particular 2F.2.4. (2) Application for renewal, accompanied by the required fee(s) and evidence of 18 hours of continuing education as prescribed in Appendix 2F, shall be submitted at least thirty (30) calendar days prior to the expiration of each three year registration period Qualified Mammographer. (1) Prior to performing any mammography examination in the State of Colorado, each individual operator shall be a qualified mammographer who meets the adequate radiation safety training and experience qualification criteria established in Appendix 2M. DEPARTMENT NOTICE OF REGISTRATION Requirements Applicable to Issuance and Maintenance of Department Registration Upon a determination that an applicant meets the requirements of the regulations, the Department shall issue a Notice of Registration The Department may incorporate in the Notice of Registration at the time of issuance, or thereafter by appropriate rule, regulation, or order, such additional requirements and conditions with respect to the registrant's activities as the Department deems appropriate or necessary Approval to conduct or perform activities in accordance with the registration requirements of these regulations shall be: Code of Colorado Regulations 8

9 (1) For a period of two (2) years, except as otherwise specified by these regulations or the Department; and (2) Limited to the category or categories of activities specifically designated The registrant shall notify the Department in writing within thirty (30) calendar days of making any change which would render inaccurate the information contained in the application for registration and/or the Notice of Registration. (1) Each servicing and services registrant under shall notify the Department each time the registrant adds a service technician (or several service technicians at the same time) to the list of service technicians authorized to provide radiation machine service(s). (a) The registrant will be assessed an acceptance review fee as required by Part 12 for each list change. (b) Changes made during renewal will not be assessed an acceptance review fee Except as provided by , each Notice of Registration shall expire at the end of the month in the year stated therein In any case in which a registrant, not less than thirty (30) calendar days prior to the expiration of the registrant s authorization, has filed an application in proper form for renewal or for a new registration authorizing the same activities, such existing authorization shall not expire until final action by the Department The Department may not review or otherwise process a new application or application for renewal for which no remittance is received. (1) An application that is incomplete or not accompanied by the prescribed fee(s) will not necessarily be returned to the applicant. (2) All application fees are non-refundable The Department may deny, withdraw, limit or qualify its approval of any person to perform activities upon determining that such action is necessary in order to prevent undue hazard to health and safety, or for other reasonable cause Peremptory Registrant Obligations Whenever a business relationship exists between the qualified inspector and services and servicing provider, a Notice of Registrant's Rights Form R-65 shall be furnished to the registrant prior to beginning the service or evaluation, including: (1) When a qualified inspector is also authorized to perform services and servicing; (2) When a qualified inspector is also a qualified expert; and (3) When a qualified inspector, a qualified expert and/or a services and servicing provider is a member of the same corporation, partnership or other formal business relationship. Code of Colorado Regulations 9

10 No person, in any advertisement, shall refer to the fact that the person is registered with the Department pursuant to the provisions of 2.4.1, 2.4.2, and 2.4.4, and no person shall state or imply that the quality of conduct or performance of any activity under such registration has been approved or endorsed by the Department. CERTIFICATION EVALUATION 2.5 Certification Evaluations Frequency of Certification Evaluations Each radiation machine registrant shall have its radiation machine(s) and facility evaluated by a Department-approved qualified inspector annually, except as provided in through (section is summarized in Table 2-1). (1) Each certification evaluation shall be capable of determining that the machine is safe for each intended use and in compliance with the specifications of the equipment manufacturer and these regulations. (2) Each certification evaluation is in addition to and not intended to replace the manufacturer(s) recommended equipment service and/or repair procedures or facility quality assurance programs. (3) Each certification evaluation subsequent to the initial certification evaluation shall be completed in or prior to the same calendar month as the previous certification evaluation. (4) The calendar month of a certification evaluation of a machine in any month prior to the month in which it is due shall become the calendar month in which the subsequent certification is due. (5) A certification evaluation conducted after the month in which it was due shall not alter or change the month in which subsequent certification evaluations are due Each non-healing-arts fixed industrial radiography, analytical, cabinet, or self contained airport or port of entry inspection x ray imaging machine or system shall be inspected at least every two (2) years Each bone densitometry, dental, podiatry or veterinary radiation machine shall be inspected at least every three (3) years, except that: (1) Each radiographic x-ray machine or tomographic or computed tomographic system that is capable of a variable kilovoltage peak (kvp) or variable milliamperage (ma) or variable collimation and used in non-intraoral dentistry or podiatry shall be inspected annually. (2) Each machine used in podiatry that is capable of operating at more than 30 ma shall be inspected annually. (3) Each volumetric dental imaging system shall be inspected annually Each human use portable hand-held instrument used for any purpose shall be inspected annually. TABLE 2-1: SUMMARY OF FREQUENCY OF RADIATION MACHINE INSPECTION Code of Colorado Regulations 10

11 Category Each radiation machine, including under reciprocity, unless otherwise provided below: Each non-healing-arts fixed industrial radiography or analytical, cabinet, airport or port-of-entry x ray machine or system Each bone densitometry, dental, podiatry or veterinary radiation machine, except as required below: Pursuant to (1), each radiographic x-ray machine or tomographic or computed tomographic system used with a variable setting (kvp, ma or collimation) in non-intraoral dentistry or podiatry Pursuant to (2), each x-ray machine used in podiatry at more than 30 ma Pursuant to (3), each volumetric dental imaging system Pursuant to , each human use hand-held x-ray machine Frequency Every year Every two years Every three years Every year Every year Every year Every year Each new installation of a radiation machine system or replacement component that will affect or could potentially affect radiation output shall be evaluated within no more than ninety (90) calendar days of installation Each new installation of a mammography system shall be evaluated by a qualified inspector authorized in mammography prior to being used to perform any human examination Any radiation machine and/or facility not inspected in accordance with through , or otherwise determined to be out of compliance with these regulations, shall be subject to a Department enforcement inspection and subject to the fees specified in Part Procedures for Certification Evaluations by Qualified Inspectors Each qualified inspector who performs a certification evaluation of a radiation machine and/or facility evaluation shall use procedures that are sufficient to determine compliance with these regulations If a radiation machine fails to meet any requirement specified by these regulations, including manufacturer's required specifications, the qualified inspector shall immediately so inform the registrant and/or RSO designated pursuant to If the radiation machine is determined to be unsafe (as provided in Part 6 and described in Appendix 6D), the qualified inspector shall affix to such radiation machine system, in a location clearly visible to the patient, an "Unsafe for Use" label authorized and issued by the Department, indicating, as applicable, that such machine is not authorized for human, animal or other use Reporting and Labeling Procedures. (1) Each qualified inspector shall certify each determination of compliance and be responsible to provide an accurate and complete Certification Evaluation Report to the registrant and to the Department on Form R-59-1, X ray Machine Certification Evaluation Report, in accordance with the instructions contained in that form. Code of Colorado Regulations 11

12 (a) A clear and legible report may be substituted for Form R 59 1, provided that it is in the same format and provides all of the information required by Form R (b) Violations of the regulations not related to the performance of the specific radiation machine(s) shall be reported to the Department using Form R 59 2, X-ray Facility Compliance Evaluation Report, in accordance with the instructions contained in that form. (2) A qualified inspector shall provide to the registrant and Department a copy of the R or R-59-2 Report. (a) The Report shall indicate full or partial compliance and any specific violation of these regulations. (b) The Report shall include recommendations for corrective actions by the registrant (if applicable) to assist in achieving full compliance and/or improving radiation safety and the quality of the imaging process. (c) The Report shall be received by the Department no later than fifteen (15) calendar days after the inspection date, unless otherwise authorized by the Department. (3) The qualified inspector shall personally affix, or personally direct the registrant exactly how and where to affix, a certification label issued by the Department in a location clearly visible to the machine operator and patient, if (and only if) and when it is determined that the requirements of these regulations, including manufacturer's required specifications, are fully met. (a) For a machine that was found to be in full compliance, the certification label shall be affixed no later than fifteen (15) calendar days (unless otherwise authorized by the Department) after the inspection date. (b) For a noncompliant machine, the certification label shall be affixed no later than fifteen (15) calendar days (unless otherwise authorized by the Department) after the date that full compliance was achieved. (4) Each qualified inspector shall ensure that the following closeout documentation is provided to the Department to confirm that each violation was corrected as required by and/or within thirty (30) calendar days of the date of inspection. (a) For a noncompliant machine for which full compliance has been achieved, the completed documentation (on Form R-59-1 or equivalent, signed by the qualified inspector as completed and including the number of the label that was affixed) shall be received by the Department no later than fifteen (15) calendar days after the date that compliance was achieved. (b) For a noncompliant facility, the completed documentation (on Form R 59-2 or equivalent signed by the registrant as completed) shall be received by the Department no later than fifteen (15) calendar days after the date that full compliance was achieved. (5) Concealing, defacing or altering of Department-issued labels is prohibited. Code of Colorado Regulations 12

13 (6) Repeated failure to affix certification labels and/or to accomplish timely completion of certification evaluation reports as provided in this subsection shall be subject to review and audit as provided in 2.9 and also subject to the non routine inspection fee as provided in Part Facility Registrant Responsibilities In any facility regulated by or requiring registration under these regulations, the registrant shall allow only individuals who are adequately trained in radiation safety and the safe and effective use of the machine to operate any radiation machine The facility registrant shall document evaluation of the qualifications of each individual permitted to operate any radiation machine at the facility. (1) Each operator shall meet all radiation safety training and experience requirements of the respective State of Colorado professional licensure board, as applicable, and any applicable requirements of this Part 2. (2) Consistent with (3)(b), the registrant shall maintain a list of operators (or have a policy in place that specifies how such a list will be provided on request) who have been determined to be adequately trained in accordance with these regulations. (a) For fluoroscopy equipment used in examination of a living human, a list of qualified individuals shall be maintained as required by (b) The list of all operators qualified for fluoroscopy shall be updated at least annually as part of the radiation safety program required by 4.5. (3) Records of such evaluations shall: (a) Include current certifications of qualification; (b) Be maintained by the facility; and (c) Be produced for examination upon request during any inspection conducted under the requirements of these regulations A physician, chiropractor, dentist, podiatrist, or veterinarian who has a current active license from the appropriate State of Colorado professional licensure board is considered to have demonstrated adequate training in radiation safety and the safe and effective use of the radiation machine (consistent with ) and may operate radiation machines as part of medical, chiropractic, dental, podiatric or veterinary practice, respectively For a radiologist assistant adequately trained shall mean that the individual is qualified as provided in Appendix 2G For any radiographic x-ray system used on a living human (not inconsistent with , , and through ), adequately trained shall mean that the individual meets the requirements of Appendix 2D. (1) Limited-scope x-ray machine operator approval is limited to imaging procedures for x- ray examination of the skull, chest, hip/pelvis and spine/sacrum, upper extremities and lower extremities. Code of Colorado Regulations 13

14 (2) A limited-scope x-ray machine operator shall not perform radiologic procedures involving the administration or utilization of contrast media, bone density or fluoroscopic equipment, mammography, computed tomography, or radiation therapy procedures For fluoroscopy equipment used in examination of a living human, adequately trained shall mean that, in addition to meeting all applicable requirements in through , each healing arts facility shall make a written determination that any individual who either supervises a fluoroscopy procedure or operates a fluoroscopy imaging system has adequate training in its safe operation, including documented training in the following: (1) Fundamental principles of radiation protection; (2) Biological effects of ionizing radiation; (3) Safe operation of fluoroscopy equipment for each mode of operation to be used; (4) Dose reduction techniques for fluoroscopy; and (5) Applicable radiation regulations For mammography equipment used in radiography of the human breast, adequately trained shall mean that the individual operator meets the registration and/or other requirements of Appendix 2M For any computed tomography system used on a living human, adequately trained shall mean that the individual operator meets the registration and/or other requirements of Appendix 2E For any bone densitometry equipment used in examination of a living human, adequately trained shall mean that the individual operator meets the registration and/or other requirements of Appendix 2F For radiographic equipment used in the practice of medicine, adequately trained shall mean that the individual operator meets all applicable requirements of the Colorado State Board of Medical Examiners (in particular Rule 700, State Board of Medical Examiners Rules and Regulations Regarding Education and Training Standards for Unlicensed Personnel Exposing Ionizing Radiation of 3 CCR ) For radiographic equipment used in chiropractic, adequately trained shall mean that the individual operator meets all applicable requirements of the Colorado State Board of Chiropractic Examiners (in particular Rule 19, Safety Training for Unlicensed Chiropractic Personnel, of 3 CCR 707-1) For radiographic equipment used in dentistry, adequately trained shall mean that the individual operator meets all applicable requirements of the Colorado State Board of Dental Examiners (in particular Rule X, Minimum Standards for Qualifications, Training and Education for Unlicensed Personnel Exposing Patients to Ionizing Radiation, of 3 CCR 709-1) For radiographic equipment used in podiatry, adequately trained shall mean that the individual operator meets all applicable requirements of the State of Colorado Podiatry Board (in particular Rule 700 of 3 CCR 712-9). Code of Colorado Regulations 14

15 For radiographic equipment used in veterinary medicine, adequately trained shall mean that the individual operator meets all applicable requirements of the State of Colorado Board of Veterinary Medicine (in particular 4 CCR 727 1) An individual, enrolled in an ARRT-recognized program or graduated therefrom, may operate radiation machines so long as the individual works under the direct supervision of a radiologic technologist or other qualified trainer and has documentation of having completed education and experience equal to that specified in the program. (1) A graduate from an ARRT-recognized program is granted ninety (90) calendar days from the date of graduation to schedule, take and pass the radiologic technology registry examination. (2) During the 90-day period allowed by (1), the graduate is considered to satisfy Appendix 2D. (3) A student or graduate who fails to pass the registry examination has not met the requirements of Appendix 2D and shall not operate any radiation machine system on a living human unless otherwise authorized by the Department For radiation machines used in non-healing-arts applications, adequately trained shall mean that the individual operator meets the requirements of Appendix 2N. (1) For industrial radiography, the requirements in Part 5 apply, as stated in 2N.1. (2) The requirements of 2N.2 apply to all non-healing-arts applications (including but not limited to analytical, forensic, morgue, and homeland security uses) not subject to Part For assembly, installation and repair of radiation machines, adequately trained shall mean that the individual service technician meets the requirements of Appendix 2H Department recognition of training as adequate pursuant to through shall pertain only to the areas of training and experience specifically identified in these regulations If and when an application to the Department is required, the application for adequate training review and approval or for an examination administered by the Department shall be: (1) Submitted on forms prescribed by the Department; and (2) Completed to contain all the information required by the form and all accompanying instructions; and (3) Accompanied by the application fee(s) specified in Part 12; and (4) Accompanied by evidence of continuing education, if and when required The Department may, upon application or upon its own initiative, accept as being adequate: (1) Documented combinations of radiation safety training and experience; or (2) Equivalent approval by another state or agency. Code of Colorado Regulations 15

16 2.6.2 The facility registrant shall ensure that all required certification and compliance evaluations are performed as required by in accordance with the instructions that accompany Form R-59-1, X-ray Machine Certification Evaluation Report and Form R-59-2, X-ray Facility Compliance Evaluation Report For each radiation machine finding of noncompliance (Form R-59-1), the facility registrant shall: Correct any failure of a radiation machine or imaging system to meet the requirements of these regulations or manufacturer s required specifications, within thirty (30) calendar days or as otherwise specified by the Department, in particular as identified on Form R 59 1, X ray Machine Certification Evaluation Report Not use a radiation machine that has been determined to be unsafe for use, in particular according to any of the criteria in Appendix 6D, until subsequent certification by a Department-approved qualified inspector or the Department Permit only a person who has provided evidence of current registration with the Department in accordance with to provide radiation machine servicing or services Upon correction of any radiation machine item of violation, confirm to the qualified inspector that indicated repairs have been completed. (1) A copy of the Certification Evaluation Report, Form R-59-1, with the service repair certification signed and dated by the person providing service, shall be provided to the qualified inspector who signed the original Form R (2) A copy of any service report shall be provided to the qualified inspector upon request as evidence of completed corrective action Upon correction of any item of violation identified on Form R-59-1, X ray Machine Certification Evaluation Report, retain documentation that each indicated violation has been corrected to bring the machine into compliance Pay the fee required by Part 12 for each certification label issued to the registrant by the qualified inspector For each finding of facility noncompliance (Form R-59-2), the registrant shall: Correct any violation within thirty (30) calendar days of each finding of facility noncompliance (Form R-59-2) or as otherwise specified by the Department Provide documentation to the Department to confirm that each indicated violation has been corrected to bring the facility into compliance. (1) For any item identified for correction on Form R-59-2, X-ray Facility Compliance Evaluation Report, provide a copy of the Form R-59-2 with the Registrant s Certification of Correction section signed and dated by the registrant or registrant s agent Pay any fee required by Part Record Retention and Reports. Code of Colorado Regulations 16

17 The registrant shall maintain each diagnostic image in a medical record for each patient as specified by the applicable State of Colorado professional licensure board; absent an applicable board specification, record retention shall be for a period not less than ten (10) years or any period of minority or incompetency The registrant shall maintain for the duration of the registration, records of each shielding design, and each radiation survey required by , performed for the facility. (1) Upon any transfer of ownership, such shielding design(s) and survey records shall also be transferred to the new owner The registrant shall maintain for the duration of the registration, until a machine is retired from service, the operator and service manual(s) provided by the manufacturer, if available. (1) If the operator manual is not obtainable from the manufacturer, such a manual of written operating procedures shall be developed and maintained by the registrant, including: (a) A description, including purpose and function, of each control panel knob, button, and meter; (b) Techniques for collimation and centering of the beam to the image receptor; (c) The function of all locks and detents; and (d) Emergency shutdown instructions The registrant shall maintain for inspection for a period of three (3) years for each x-ray imaging or image processing system (six years for a facility or machine inspected only every three years) records of: (1) Operator certifications; (2) Operator training; (3) Service and repair reports; (4) Radiation machine inspection certification evaluation reports; (5) Facility compliance evaluation reports; and (6) Notices of violation. 2.7 Service Company Registrant Responsibilities No person shall certify or declare that a radiation machine or component, or the supplies used in connection with such a machine or component, is ready for its intended use, unless and until: The shielding design has been completed if and as required by 6.3.2, as documented (without exception after June 30, 2010) by a comment on Form FDA 2579 or a signed and dated notification to the Department. Code of Colorado Regulations 17

18 The machine and/or component (and any associated equipment and supplies), after having properly been made operational, demonstrably meet the manufacturer specifications and the requirements of these regulations; and The registrant has been provided, by the vendor, assembler and/or services and servicing personnel, as required by the Federal Performance Standard (21 CFR Chapter I, Subchapter J, April 1, 2010) and these regulations, the following: (1) All guidance documents, including instruction manuals, manufacturer specifications and information notices, that are applicable to each newly installed radiation machine system or component; and (2) A checklist of the registrant s responsibilities under these regulations, including but not limited to requirements of 2.6.3, in particular Any person who sells, leases, transfers, lends, assembles, installs, trades out or disposes any radiation machine, or component, which affects radiation output in this State shall notify the Department in writing within fifteen (15) calendar days of each transaction subject to this section with the following information: The full name and address of each person who has received the radiation machine or component and the specific location within the facility; and Specific details about the system or sub-system, including the manufacturer, model, and serial number of each radiation machine or component transferred; and The date of transfer, assembly, or installation of each radiation machine or component; and A completed Form FDA 2579 or a signed and dated affirmation that all instruction manuals, written instructions and regulations applicable to the newly installed radiation machine system or components have been delivered to the registrant A report of assembly (Form FDA 2579 or equivalent) in compliance with requirements of the Federal Performance Standard (21 CFR (d), April 1, 2010) shall be submitted to the Department within fifteen (15) calendar days following completion of the assembly or installation The assembly or installation is considered completed when the unit has properly been made operational and is ready for its intended use Form FDA 2579 or an equivalent report suffices in lieu of any reports required in If required by the Department on a Certification Evaluation Report, Form R-59-1, a service company that performs a radiation machine repair shall: RECIPROCITY Sign, as the person providing service, the service repair certification section of a copy of the original Certification Evaluation Report, Form R-59-1; Provide a copy to the qualified inspector who signed the original Certification Evaluation Report, Form R-59-1, with the service repair certification signed by the person providing service; and Provide, upon request, a copy of any additional information about the details of the repair. Code of Colorado Regulations 18

19 2.8 Out-of-State Radiation Machines Subject to these regulations, any person who desires to bring radiation machines into this state for temporary use is hereby granted authorization to conduct activities using these machines for a period not to exceed a total of 180 days in any calendar year, provided that: The out-of-state registration, and/or other documents authorizing the use of radiation machines issued by the agency having jurisdiction where the out-of-state registrant maintains an office for directing the registered activity and at which radiation safety records are normally maintained, does not limit the activity authorized by such document to specified installations or locations; and The person proposing to bring such machines into Colorado shall give written notice to the Department at least fifteen (15) calendar days before such machine is to be used in the state, unless otherwise authorized by the Department as provided in The notice shall be made using the Department's X-ray Reciprocity Request Form R-200 and shall include all information required by that form. (1) As part of this notice, the person requesting reciprocity shall certify that: (a) A copy of all applicable parts of these regulations shall be available at each use location in State of Colorado; (b) Each machine has been evaluated and determined to be in compliance with these, or equivalent, regulations; and (c) The operation of each radiation machine shall be in accordance with the applicable requirements of these regulations. (2) In the case of a request to perform a healing arts screening program within the State, submit a completed Form R-300, Application for Registration Healing Arts Screening, with the reciprocity request, including all of the information required, pursuant to Part 6, Appendix 6F, by the form and any accompanying instructions. (3) In the case of a request to perform mammography screening within the State, a copy of the facility's mammography certificate issued by the FDA (21 CFR (a), April 1, 2010) and applicable American College of Radiology credentials shall be included with the reciprocity request. (4) The person requesting reciprocity shall also supply such other information as the Department may request The out-of-state registrant complies with all applicable regulations of the Department; and The out-of-state registrant shall at all times during work at any work location within the State have available the pertinent documentation as required by these regulations, including: (1) Pertinent registration documentation; (2) Written authorization from the Department for in-state activities; (3) Applicable sections of these regulations as certified pursuant to (1)(a); Code of Colorado Regulations 19